Efficacy and Safety of PG-530742 in the Treatment of Mild to Moderate Knee Osteoarthritis - Tabular View

Tracking Information

First Received Date ^ICMJE

July 16, 2002

Last Updated Date

July 17, 2009

Start Date ^ICMJE

January 2002

Primary Completion Date

February 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Minimum joint space width in teh medial compartment of the tibiofemoral joint of the knee at one year [ Time Frame: One year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00041756 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Efficacy and Safety of PG-530742 in the Treatment of Mild to Moderate Knee Osteoarthritis

Official Title ^ICMJE

Efficacy and Safety of PG-530742 in the Treatment of Mild to Moderate Knee Osteoarthritis

Brief Summary

Matrix metalloproteinases have been implicated in the cartilage degradation that occurs in osteoarthritis. PG-530742 inhibits some of these matrix metalloproteinases, thus potentially limiting cartilage degradation and disease progression. This study will test the efficacy and safety of PG-530742 in the treatment of mild to moderate knee osteoarthritis.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Osteoarthritis, Knee

Intervention ^ICMJE

Drug: PG-530742
Drug: Placebo tablet,
Drug: 50 mg PG-530742
Drug: 100 mg PG-530742
Drug: 200 mg PG-530742

Study Arms / Comparison Groups

Placebo Comparator: Placebo tablet
Experimental: 25 mg PG-530742
Experimental: 50 mg PG-530742
Experimental: 100 mg PG-530742
Experimental: 200 mg PG-530742

Publications *

Krzeski P, Buckland-Wright C, Bálint G, Cline GA, Stoner K, Lyon R, Beary J, Aronstein WS, Spector TD. Development of musculoskeletal toxicity without clear benefit after administration of PG-116800, a matrix metalloproteinase inhibitor, to patients with knee osteoarthritis: a randomized, 12-month, double-blind, placebo-controlled study. Arthritis Res Ther. 2007;9(5):R109.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

401

Completion Date

February 2004

Primary Completion Date

February 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

mild to moderate knee osteoarthritis confirmed by a radiographic technique.

Exclusion Criteria:

secondary knee osteoarthritis;
diseases other than osteoarthritis that could cause knee pain;
any disease or intervention (surgery, intra-articular injection) that would have an impact on knee pain or mobility;
drugs that act potentially on the bone or cartilage component of the knee joint.

Gender

Both

Ages

40 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Hungary, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00041756

Responsible Party

John Beary, MD, Procter and Gamble Pharmaceuticals

Study ID Numbers ^ICMJE

2001065

Study Sponsor ^ICMJE

Procter and Gamble

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

John Beary, MD

Procter and Gamble

Information Provided By

Procter and Gamble

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP